Access trocar and related method thereof

ABSTRACT

System and method that is directed to medical treatments of organs having anatomical spaces, such as (but not limited to) the heart and the pericardial space. Specifically, an apparatus and method is provided for safely accessing anatomical spaces with surfaces to deliver medical devices or media into such spaces, or to remove fluids from such spaces. The methods and apparatus may include a first elongated member with a sharp tip used to penetrate the surface surrounding the anatomical space with a second elongated member with a helical tine used to engage the surface and lift the surface away from the underlying anatomical space. Once the first elongated member has incised the surface, it is removed, and the incision may be used as a point of entry for delivering media or medical devices into the anatomical space, or for carrying out further medical procedures.

RELATED APPLICATIONS

This application is a national stage application of InternationalApplication No. PCT/US2010/033189 filed Apr. 30, 2010 and claimspriority under 35 U.S.C. §119(e) to U.S. Provisional Application Ser.No. 61/174,763, filed May 1, 2009, the disclosures of which areincorporated by reference herein in their entireties.

FIELD OF THE INVENTION

The present invention generally relates to medical treatments of organshaving anatomical spaces, such as (but not limited to) the heart and thepericardial space. Specifically, the present invention relates to anapparatus and method for safely accessing anatomical spaces withsurfaces to deliver medical devices or media into such spaces, or toremove fluids from such spaces.

BACKGROUND OF THE INVENTION

The heart muscle is surrounded by tissue known as the pericardial sac,which consists of several layers of tissue. The outermost of theselayers is the fibrous pericardium. Inside the fibrous pericardium is theserous pericardium. The serous pericardium consists of three parts: theparietal pericardium, which is bonded to the inside of the fibrouspericardium; the innermost visceral pericardium; and a fluid-containingpotential space between the parietal pericardium and the visceralpericardium called the pericardial space. Inside the visceralpericardium is the myocardium, the actual heart muscle itself.

Epicardial procedures on the heart are growing in number, efficacy, andcomplexity. Currently, ablations for ventricular tachycardia and atrialfibrillation as well as intra-cardiac procedures for valve repair aredone using approaches on the outside of the heart. Establishingepicardial access is often difficult and frequently requires theassistance of a surgeon. Similar difficulties exist in establishingaccess to other anatomical spaces with surfaces, such as the kidneys,the dura mater of the brain, blood vessels, and the peritoneum.

Several conventional devices establish access to such anatomical spacesusing vacuum or forceps. One problem with vacuum designs is that it isdifficult to maintain the vacuum seal on the pericardium required tocreate and uphold a bleb. Additionally, if the vacuum seal is broken,the tissue bleb may re-collapse away from the tip of the suction probe,thus interrupting the procedure. Vacuum suction is also likely to causetrauma and scarring to the pericardium. Moreover, vacuum designs arelikely to clog on other bodily tissues encountered before reaching thepericardium. Forceps designs also pose several problems. First, forcepsdesigns provide an uncertain grasp on the pericardium. Second, forcepsdevices require such shallow approach angles that they often havedifficulty grasping the pericardium. Moreover, such forceps devicesrequire that large incisions be made in the subject in order to providea large enough window to facilitate their use.

Conventional approach with penetration devices and access tubes do notgrip the anatomical surface with uniform force, increasing the risk oftearing. Additionally, significant mechanical difficulties areencountered with fat and other tissue in the body before reaching theanatomical surface, as fat and tissue may become caught in thepenetrating elements and restrict further movement.

There is therefore a need in the art for a safe, consistent, accurate,and easy to use percutaneous system to access the pericardial space.Similar needs arise in the context of accessing other anatomical spaceswith surfaces as well.

SUMMARY OF THE INVENTION

By practicing the methods and apparatus of various embodiments of thepresent invention, the skilled practitioner can easily and safely accessthe underlying anatomical space. An aspect of an embodiment of thepresent invention provides, but not limited thereto, a first elongatedmember with a sharp tip used to penetrate the surface surrounding theanatomical space with a second elongated member with a helical tine usedto engage the surface and lift the surface away from the underlyinganatomical space. Once the first elongated member has incised thesurface, it is removed, and the incision may be used as a point of entryfor delivering media or medical devices into the anatomical space, orfor carrying out further medical procedures.

An aspect of an embodiment of the present invention may be used toaccess any anatomical space with a surface. Anatomical spaces that maybe accessed with various embodiments may include but are not limited tothe pericardial space, the interior of the kidneys, the brain, bloodvessels, the peritoneal cavity, the spinal cord, the intra-abdominalspace, the intra-thoracic space or any space in the body bounded by amembrane or membranous entity. Surfaces include but are not limited tothe parietal pericardium, the renal capsule, the dura mater, bloodvessel walls, the peritoneum, the dural lining of the spinal cord, thepleura, the seurosa, or any other membrane in the body. It should beappreciated that the various embodiments may be practiced not only uponhuman subjects but upon animal subjects as well.

Media may comprise a pharmaceutically active substance, cells, fluids,biological fluids, drugs, gene therapy vectors, irrigation fluids,growth factors, nuclear medicine agents, antibiotics, anti-viral agents,contrast agents, chemotherapies, or other diagnostic or therapeuticagents.

Medical devices may include but are not limited to sheath catheters,ablation catheters, guide wires, other catheters, visualization andrecording devices, lumens, steering devices or systems, drug or celldelivery catheters, fiber endoscopes, suctioning devices, irrigationdevices, electrode catheters, needles, optical fiber sensors, sources ofillumination, vital signs sensors, pacing leads, cathode or otherelectrodes, fluid delivery or removal means, devices for delivering andunfurling or spreading surface patches or coverings onto the heart,biopsy devices, suture- or staple-placement devices, endoscopes,fiber-optic probes, temperature sensors, pH or other chemical sensors,feedback or regulation devices, batteries or other energy sources,cryoprobes, laser light delivery probes, artherectomy devices,angioplasty devices, surgical devices, and the like.

An advantage conferred by an aspect of an embodiment of the presentinvention is that the single point of contact made helical tineminimizes the resistance faced by the apparatus as it passes throughother tissue such as fat and muscle in order to reach the surface of theanatomical space. Another advantage of using aspect of an embodiment ofthe present invention is a minimized risk of tearing the anatomicalsurface as it is lifted away from the anatomical space, since thehelical tine provides a stable and uniform distribution of lift acrossthe anatomical surface after it has engaged the surface. Thus, theteachings of the present invention overcome the limitations of the priorart devices by consistently, safely, and stably lifting the surface fromthe anatomical space in order to establish access to the anatomicalspace.

An aspect of an embodiment of the present invention provides methods andapparatus used to implement a novel approach for accessing anatomicalspaces with surfaces safely, consistently, accurately, and with ease. Anaspect of an embodiment of present the invention, the apparatus isadvanced through the body to abut the parietal pericardium or otheranatomical surface. The apparatus is then turned so that the helicaltine of the second elongated member penetrates and engages the surfaceand draws it in a proximal direction, thereby enlarging the anatomicalspace and pulling the surface onto the sharpened first elongated member,causing the first elongated member to incise the anatomical surface.Once the anatomical surface has been penetrated, the first elongatedmember is withdrawn in a proximal direction. After the first elongatedmember has been at least partially withdrawn, medical devices or mediamay be inserted through the incision into the anatomical space, with thesecond elongated member left in place in order to maintain the expansionof the anatomical space. In an aspect of an embodiment of this method,the medical devices or media are inserted into the anatomical spacethrough the second elongated member while its helical tine remainsengaged with the surface.

In an aspect of an embodiment of the present invention, the apparatus isadvanced through the body to abut the parietal pericardium or otheranatomical surface. The apparatus is then turned so that the helicaltine of the second elongated member penetrates and engages the surfaceand draws it in a proximal direction, thereby enlarging the anatomicalspace and pulling the surface onto the sharpened first elongated member,causing the first elongated member to incise the anatomical surface.Once the anatomical surface has been penetrated, the first elongatedmember is withdrawn in a proximal direction. After the first elongatedmember has been withdrawn, a guide wire may be inserted through theincision into the anatomical space. Once the guide wire has beeninserted into the anatomical space, the second elongated member isrotated so that its helical tine disengages from the surface. Once thesecond elongated member is no longer engaged with the surface, it iswithdrawn in a proximal direction.

In an aspect of an embodiment of the present invention, the apparatusmay be equipped with actuating means to control precisely the movementof the helical tine in order to improve the safety of access proceduresand to stabilize the helical tine's grip on the surface.

An aspect of an embodiment of the present invention may comprise imagingcomponents of the apparatus so that the practitioner may determine theposition of the device within the subject's body. For example, the sharpend of the first elongated member may be adapted to be used with animaging device. In a currently preferred embodiment, the sharp end isechogenic, meaning that it is adapted to scatter ultrasonic waves. Byusing an ultrasonic transducer in conjunction with an imaging device andin conjunction with the echogenic sharp end, the practitioner of theinvention may precisely determine the position of the sharp end of thefirst elongated member within the body. In an embodiments, any componentof any embodiment of the apparatus may be adapted for use withultrasound or with other medical imaging modalities, including but notlimited to magnetic resonance imaging, computed tomography, fluoroscopy,or other radiological modalities.

An aspect of an embodiment of the present invention provides anapparatus for accessing a subject's anatomical space having a surface.The apparatus may comprise: a first elongated member comprising aproximal end and a distal end, wherein the distal end includes a sharpend or portion. The apparatus may comprise: a second elongated membercomprising a proximal end and a distal end, wherein the distal endincludes a helical tine. The helical tine is configured to: engage andpenetrate the surface of the anatomical space, wherein when the secondelongated member is turned the helical tine lifts the surface in aproximal direction. This lifting assists in advancing the surface incontact with the sharp end (or portion) to cause an incision of thesurface by the sharp end (or portion).

An aspect of an embodiment of the present invention provides a methodfor accessing a subject's anatomical space having a surface. The methodmay comprise: providing a first elongated member having a proximal endand a distal end, wherein the distal end includes a sharp end orportion. The method may further comprise: providing a second elongatedmember having a proximal end and a distal end, wherein the distal endincludes a helical tine. The method may further comprise: engaging thesurface of the anatomical space with the helical tine. The method mayfurther comprise: turning the helical tine to cause lifting of thesurface in a proximal direction, whereby the lifting assists inadvancing the surface in contact with the sharp end or portion to causean incision of the surface by the sharp end or portion.

System and method that is directed to medical treatments of organshaving anatomical spaces, such as (but not limited to) the heart and thepericardial space. Specifically, an apparatus and method is provided forsafely accessing anatomical spaces with surfaces to deliver medicaldevices or media into such spaces, or to remove fluids from such spaces.The methods and apparatus may include a first elongated member with asharp tip used to penetrate the surface surrounding the anatomical spacewith a second elongated member with a helical tine used to engage thesurface and lift the surface away from the underlying anatomical space.Once the first elongated member has incised the surface, it is removed,and the incision may be used as a point of entry for delivering media ormedical devices into the anatomical space, or for carrying out furthermedical procedures.

An aspect of an embodiment of the present invention may comprise sensingthe pressure regimes of the subject's body so that the practitioner mayaccurately navigate the device within the subject's body. An embodimentof this aspect may comprise an access needle configured to monitorpressures as the access needle is advanced through the body.

The invention itself, together with further objects and attendantadvantages, will best be understood by reference to the followingdetailed description taken in conjunction with the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings illustrate several aspects and embodiments ofthe present invention, and, together with the description herein, serveto explain the principles of the invention. The drawings are providedonly for the purpose of illustrating select embodiments of the inventionand are not to be construed as limiting the invention.

FIG. 1 depicts an embodiment of the first elongated member

FIG. 2 depicts an embodiment of the second elongated member.

FIG. 3 depicts the embodiment of the first elongated member of FIG. 1and the embodiment of the second elongated member of FIG. 2 used intandem, with the first elongated member housed inside the secondelongated member.

FIG. 4 depicts the embodiment in FIG. 3 in use as it engages theanatomical surface.

FIG. 5 depicts the embodiment in FIG. 3 in use as it enlarges theanatomical space.

FIG. 6 depicts the embodiment in FIG. 3 in use as it penetrates theanatomical surface.

FIG. 7 depicts the first elongated member of an alternate embodiment.

FIG. 8 depicts the second elongated member of an alternate embodiment.

FIG. 9 depicts the embodiment of the first elongated member of FIG. 7and the embodiment of the second elongated member of FIG. 8 used intandem, with the second elongated member housed inside the firstelongated member.

FIG. 10 depicts the embodiment in FIG. 9 in use as it engages theanatomical surface.

FIG. 11 depicts the embodiment in FIG. 9 in use as it enlarges theanatomical space.

FIG. 12 depicts the embodiment in FIG. 9 use as it penetrates theanatomical surface.

FIG. 13 is a top-down cross-section view of an embodiment of the meansused to hold the first elongated member in a fixed position with respectto the second elongated member.

FIG. 14 depicts the embodiment of the invention in FIG. 3 used inconjunction with an access needle and pressure-sensing means.

FIG. 15 depicts an embodiment of the first elongated member of FIG. 1adapted for use with an imaging system.

FIG. 16 depicts an embodiment of the invention incorporating an imagingsystem and the first elongated member depicted in FIG. 15.

FIG. 17 depicts an embodiment incorporating a third elongated membersubstantially enclosing the embodiment of FIG. 3.

FIG. 18 depicts an alternate embodiment of the third elongated memberwith an alternate embodiment of the helical tine of the second elongatedmember.

FIG. 19 depicts the embodiment in FIG. 17 with an optional skin bumperfor stabilizing the device at the skin.

FIG. 20 depicts grooves in the second elongated member of the embodimentin FIG. 17.

FIG. 21 depicts the actuator system for use with the embodiment in FIG.20.

FIG. 22 depicts the embodiment in FIG. 17 with an optional side port.

FIG. 23 depicts the withdrawal of the first elongated member once theanatomical space has been accessed using the embodiment in FIG. 3.

FIG. 24 depicts the embodiment of FIG. 23 wherein the second elongatedmember remains in place for use in introducing medical devices into theanatomical space.

FIG. 25 depicts the embodiment of FIG. 24 wherein a guide wire isintroduced into the anatomical space.

FIG. 26 depicts the embodiment of FIG. 25 wherein second elongatedmember is disengaged from the surface and withdrawn after the guide wirehas been introduced into the anatomical space.

DESCRIPTION OF THE SPECIFIC EMBODIMENTS

FIG. 1 shows an embodiment of the first elongated member 100. Thiselongated member comprises a proximal end 101 and a distal end 102.Disposed at the distal end 102 is a sharp end 103 that may be configuredso as to provide a sharp point 106. It should be appreciated that thesharp end may be a variety of sharp structures or points such as beveledstructure, serrated structure, tapered structure, or cutting edgestructure, etc. In an approach, the first elongated member 100 may beconfigured as a cylinder, rectangular, prism, tube, shaft or othergeometric shape as desired or required, with a length of about 1 cm toabout 40 cm or as desired or required, and a width of about 1 mm toabout 15 mm or as desired or required. It should be appreciated thatthat other lengths, shapes, contours and cross-sections may be used. Thefirst elongated member 100 may be hollow or solid. The sharp point 106may be configured as any one of a variety of structures, including butnot limited to beveled structure, serrated structure, tapered structure,or cutting edge structure. In an embodiment, the first elongated member100 may be composed of surgical-grade stainless steel, such as 306stainless steel. In other embodiments, the first elongated member 100may be composed of materials selected to be compatible with variousmedical imaging modalities, including but not limited to ferrous metalsand alloys; non-ferrous metals and alloys such as titanium, nitinol, ormagnesium; or plastics.

FIG. 2 shows an embodiment of the second elongated member 200 of theinvention. This elongated member comprises a proximal end 201 and adistal end 202. Disposed at the distal end 202 is a helical tine 205configured as a corkscrew or the like. The axis of the helical tine 205may be angled with respect to the longitudinal axis defined by thesecond elongated member 200 at a range of varying degrees from 0 degreesto 90 degrees, and preferably between about 10 and about 35 degrees, oras desired or required, so that when turned it can engage the anatomicalsurface. The helical tine 205 may subtend about 30 degrees of arc toabout 360 degrees of arc, or as desired or required. Running through thesecond elongated member 200 is at least one lumen 208. In an embodiment,the second elongated member 200 is configured as a cylinder, cylinder,rectangular, prism, tube, hollow shaft or other geometric shape asdesired or required, with a length of about 1 cm to about 40 cm or asdesired or required and a width of about 1 mm to about 15 mm or asdesired or required. It should be appreciated that other lengths,shapes, contours and cross-sections may be used. In an embodiment, thesecond elongated member 200 may be composed of surgical-grade stainlesssteel, such as 306 stainless steel. In other embodiments, the secondelongated member 200 may be composed of materials selected to becompatible with various medical imaging modalities, including but notlimited to ferrous metals and alloys; non-ferrous metals and alloys suchas titanium, nitinol, or magnesium; or plastics. In an embodiment, theshape of the lumen 208 is also adapted to house the first elongatedmember 100.

FIG. 3 shows an embodiment of the apparatus 500 comprising the firstelongated member 100 and the second elongated member 200. The firstelongated member is inserted through the lumen 208 of the secondelongated member 200 and housed therein. In an embodiment, the twoelongated members may be selectively held in a fixed position relativeto each other. It should be appreciated that the means for the selectiveholding may be a variety of approaches. For example, FIG. 13 depicts anembodiment of this selective hold aspect comprising switchablespring-ball mechanism 209 comprising a non-deformable high friction ballattached to a spring disposed inside the lumen 208 of the secondelongated member 200. The ball of the spring-ball mechanism 209 pressesagainst the first elongated member 100 and holds it in place inside thelumen 208. Moreover, for example, grooves, high-friction materials, orother structures disposed on either the first elongated member 100 orthe second elongated member 200 may also be employed to hold orselectively hold the two elongated members in a fixed position withrespect to each other.

FIGS. 4-6 depict the embodiment of the apparatus 500 in use. Once theapparatus is in place or adjacent to the surface 000 of the anatomicalspace 001, as shown in FIG. 4, the helical tine 205 can engage andpenetrate the surface 000 when it rotated. As shown in FIG. 5, as thehelical tine is rotated, the helical tine 205 draws (or advances) thesurface 000 in a proximal direction, causing an expansion of theanatomical space 002. As shown in FIG. 6, the helical tine may continueto be turned so as to cause the helical tine 205 to draw (or advance)the surface 000 onto the sharp point 106 (or sharp end 103) of the firstelongated member 100 so as to cause an incision 003 in the surface 000by the sharp point 106. It should be appreciated that in addition to therotation of the helical tine 205, the incision 003 by the sharp point106 may be also be effected by 1) moving the first elongated member 100in a distal direction, 2) moving the second elongated member 200 in aproximal direction, or 3) moving the first elongated member 100 in adistal direction and moving the second elongated member 200 in aproximal direction. It should be appreciated that any of the drawing(advancing) and moving (distally/proximally) may be accomplishedsimultaneously, sequentially or any combination thereof.

FIG. 7 depicts an embodiment of the first elongated member 110. Thiselongated member comprises a proximal end 101 and a distal end 102.Disposed at the distal end 102 is a sharp end 103 configured as a sharprim 105. Running through the alternate first elongated member 110 is alumen 104. In an approach, the first elongated member 110 may beconfigured as a cylinder, rectangular, prism, tube, hollow shaft orother geometric shape as desired or required, with a length of about 1cm to about 40 cm or as desired or required and a width of about 1 mm toabout 15 mm or as desired or required. It should be appreciated thatthat other lengths, shapes, contours, and cross-sections may be used. Inan embodiment, the first elongated member 110 is composed ofsurgical-grade stainless steel, such as 306 stainless steel. In otherembodiments, the first elongated member 110 may be composed of materialsselected to be compatible with various medical imaging modalities,including but not limited to ferrous metals and alloys; non-ferrousmetals and alloys such as titanium, nitinol, or magnesium; or plastics.In an embodiment, the lumen 104 of the first elongated member 110 may beadapted to house the second elongated member 210, shown in FIG. 8. Itshould be appreciated that the lumen 104 and the second elongated member210 may be configured to accommodate other devices or structures. In anembodiment, the second elongated member 210 may be hollow or solid.

FIG. 8 shows an embodiment of the second elongated member 210 of theinvention. This elongated member comprises a proximal end 201 and adistal end 202. Disposed at the distal end 202 is a helical tine 205configured as a corkscrew or the like. The axis of helical tine 205 maybe angled with respect to the longitudinal axis defined of the secondelongated member 200 at a range of varying degrees from about 0 degreesto about 90 degrees, and preferably between 10 and 35 degrees, or asdesired or required, so that when turned it can engage the anatomicalsurface. The helical tine 205 may subtend about 30 degrees of arc toabout 360 degrees of arc, or as desired or required. Running through thesecond elongated member 200 is at least one lumen 208. In an embodiment,the second elongated member 200 is configured as a cylinder, cylinder,rectangular, prism, tube, hollow shaft or other geometric shape asdesired or required, with a length of about 1 cm to about 40 cm or asdesired or required and a width of about 1 mm to about 15 mm or asdesired or required. It should be appreciated that other lengths,shapes, contours, and cross-sections may be used. In an embodiment, thesecond elongated member 210 may be composed of surgical-grade stainlesssteel, such as 306 stainless steel. In other embodiments, the secondelongated member 200 may be composed of materials selected to becompatible with various medical imaging modalities, including but notlimited to ferrous metals and alloys; non-ferrous metals and alloys suchas titanium, nitinol, or magnesium; or plastics.

FIG. 9 shows an embodiment of the apparatus 500 comprising the firstelongated member 110 and the second elongated member 210. The secondelongated member 210 is inserted through the lumen 104 of the firstelongated member 110 and housed therein. In a currently preferredembodiment, the two elongated members may be selectively held in a fixedposition relative to each other.

FIGS. 10-12 depicts an embodiment of the apparatus 500 in use. Once theapparatus is in place or adjacent to the surface 000 of the anatomicalspace 001, as shown in FIG. 10, the helical tine 205 can engage andpenetrate the surface 000 when it is rotated. As shown in FIG. 11, asthe helical tine 205 is rotated, the helical tine 205 draws (oradvances) the surface 000 in a proximal direction, causing an expansionof the anatomical space 002. As shown in FIG. 12, the helical tine 205may continue to be turned so as to cause the helical tine 205 to draw(or advance) the surface 000 onto the sharp rim 105 of the firstelongated member so as to cause incisions 003 in the surface 000 by thesharp rim 105. It should be appreciated that in addition to the rotationof the helical tine 205, the incision 003 by the sharp rim 105 may bealso be effected by 1) moving the first elongated member 100 in a distaldirection, 2) moving the second elongated member 200 in a proximaldirection, or 3) moving the first elongated member 100 in a distaldirection and moving the second elongated member 200 in a proximaldirection. It should be appreciated that any of the drawing (advancing)and moving (distally/proximally) may be accomplished simultaneously,sequentially or any combination thereof.

FIG. 14 depicts an embodiment of the apparatus 500 used in conjunctionwith an embodiment of an access needle 400 (i.e., access device)disclosed in PCT International Application Serial No. PCT/US2008/056643,filed Mar. 12, 2008, (Pub. No. WO/2008/115745, published Sep. 25, 2008),entitled “Access Needle Pressure Sensor Device and Method of Use,”, andits corresponding U.S. National Stage application Ser. No. 12/530,830,filed Sep. 11, 2009; of which the disclosure are hereby incorporated byreference herein in their entirety. In an embodiment, the access needle400 is advanced through the subject's skin 004 and thorax 005 until itis near the surface 000 of the anatomical space to be accessed. Theapparatus 500 is first presented (as shown in the top portion of thedrawing sheet) then advanced through the access needle 400 (as shown inthe lower portion of the drawing sheet). The access needle 400 mayoptionally further comprise a pressure monitoring system 402 incommunication with a side port 401 of the access needle 400. Thepressure monitoring system 402 may employ any number or type of pressuresensors, including sensors that are manometric, solid-state, optical, orotherwise sensitive to hydrostatic and hydrodynamic pressures. Moreover,other devices that the access device (access needle) may accommodatewith the practice of this invention include, but not limited thereto,the following: ablation catheters, guidewires, pacing leads, pacingcatheters, pacemakers, visualization and recording devices, drugs, anddrug delivery devices, lumens, steering devices or systems, drug or celldelivery catheters, fiber endoscopes, suctioning devices, irrigationdevices, electrode catheters, needles, optical fiber sensors, sources ofillumination, vital signs sensors, and the like Theses devices may bedeployed for procedures in an integral body part or space.

FIGS. 15-16 depict an embodiment of the first elongated member 100 ofthe apparatus 500 adapted for use with a medical imaging modality. In anembodiment, the sharp end 103 of the first elongated member 100comprises etchings 107 capable of scattering ultrasonic waves 404generated by an ultrasonic transducer 403 connected to an imagingdisplay 405 capable of displaying the combination apparatus' positionunder the skin 004. However, several modifications may be made upon thisembodiment. Any part of any constituent of the apparatus 500 could bemodified for use with the ultrasonic transducer 403 or for use with anyother medical imaging modality, including but not limited to magneticresonance imaging, computed tomography, fluoroscopy, or otherradiological modalities.

FIG. 17 depicts an embodiment of an apparatus 500 comprising a thirdelongated member 300 comprising a proximal end 301, a distal end 303,and a middle portion 302. In this embodiment, the third elongated memberencloses the second elongated member 200 and the first elongated member100. Regarding the third elongated member 300, it should be appreciatedthat the contours, shapes, lengths, and dimensions may be of any varietydisclosed for the first and second elongated members, as well as desiredor required. The third elongated member may be configured to accommodatea variety of devices or structures as desired or required. It should beappreciated that the third elongated member doesn't necessarily need tocomplete enclose the first and second elongated members.

FIG. 18 depicts an embodiment of the third elongated member 300. Thisembodiment comprises two substantially parallel tracks 310 for holdingthe first elongated member 100 and the second elongated member 200. Thesecond elongated member has disposed at its distal end 202 the helicaltine 215, wherein the helical tine has a cross-section such that thesharp end 103 of the first elongated member 100 is inside the crosssection of the helical tine 215. Regarding the third elongated member300, it should be appreciated that the contours, shapes, lengths, anddimensions may be of any variety disclosed for the first and secondelongated members, as well as desired or required. The third elongatedmember may be configured to accommodate a variety of devices orstructures as desired or required. The tracks 310 may be composed ofsilicone rubber, silicon, rubber, plastic, polymer, cloth, metal, foam,or any type of composite material or substance. In an approach, the twotracks 310 may be joined by a central body component 313. It should beappreciated that there may be less than two tracks or more that twotracks. Moreover, it should be appreciated that the first and secondelongated members may be disposed inside one another as discussed inthis disclosure, rather than side by side. Moreover, the side-by-sidearrangement of the first and second elongated members may be implementedwith the third elongated member as shown in FIG. 17, whereby the firstand second elongated members are enclosed or at least substantiallyenclosed by the third elongated member.

FIG. 19 depicts an embodiment of the apparatus 500 further comprising askin bumper 304 attached to or in communication of the exterior of themiddle portion 303 of the third elongated member 300. This skin bumper304 is used for stabilizing the combination apparatus 500 on the skin ofthe subject. In an embodiment, the skin bumper 304 may be configured asa donut composed of silicone rubber, though other geometricconfigurations, contours, shapes, sizes and materials may be used. Forexample, the skin bumper may instead be composed of silicon, rubber,plastic, polymer, cloth, metal, foam, or any other type of compositematerial or substance.

FIG. 20 depicts an embodiment of the second elongated member 200 as apart of the apparatus 500. In this embodiment, the second elongatedmember 200 further comprises a first middle portion 204 adjacent to thedistal end 202, and a second middle portion 203 adjacent to the proximalend 201. The second middle portion 203 further comprises a helicalgroove 206 bored into the surface (or provided in some appropriatetechnique) of the second elongated member 200 that terminates in aV-shape as shown (or in a shape as desired or required). The firstmiddle portion 204 further comprises an L-shaped groove 207 bored intothe surface of the second elongated member 200. The first elongatedmember 100 and second elongated member 200 are then placed inside thethird elongated member 300.

FIG. 21 depicts an embodiment of the apparatus 500 further comprising anactuator in a partially actuated state. In this embodiment, pressingdown on the actuator button 309 causes an attached driver tab 306passing through a longitudinal aperture 305 in the third elongatedmember 300 and engaged with the helical groove 206 to move in a distaldirection, causing the interior first elongated member 100 and secondelongated member 200 to advance in a distal direction whilesimultaneously causing the rotation of the second elongated member 200and attached helical tine 205 as well as the compression of a spring308. When the actuator button 309 is fully depressed, the driver tab 306moves into the V-shaped terminus of the helical groove 206, holding theinterior (i.e., first elongated member 100 and second elongated member200) in a fixed position. When the actuator button 309 is depressedagain from this position, the driver tab 306 is withdrawn from theV-shaped terminus, and the spring 308 drives the driver tab 306 back upthe helical groove 206, causing the interior combination (i.e., firstelongated member 100 and second elongated member 200 to rotate in theopposite direction and driving it in a proximal direction. In anembodiment the actuator button 309 is connected to a rigid actuatorspine 311 to the driver tab 306. In an embodiment, the apparatus 500also includes a restrictor tab 307 connected to the driver tab 306 by acompressible actuator spine 313. The restrictor tab 307 is adapted topass through the longitudinal aperture 305 and to engage the L-shapedgroove 207. This groove functions to stabilize the apparatus as it isactuated. It should be appreciated that a number of actuator devices orsystems may be utilized that are configured to longitudinally drive thehelical tine in a proximal and/or distal direction.

FIG. 22 depicts an embodiment of the apparatus 500 wherein the thirdelongated member 300 further comprises a side port 312. The side port312 may be used to infuse fluids into the anatomical space or to drainfluids from the anatomical space. The port may be utilized for egressand ingress. The port may be configured as more than one valve, two-wayvalve, channel, lumen or conduit, or the like.

FIGS. 23-26 depict various embodiments of different technique methods ofthe present invention. For instance, FIG. 23 illustrates that the firstelongated member 100 is partially withdrawn from the system in aproximal direction, after the second elongated member 200 has beenturned, the helical tine 205 has engaged and penetrated the surface 000,which as a result caused an expansion 002 of the anatomical space 001,and an incision 003 in the surface 000 by the sharp end. In an approach,the first elongated member 100 may be completely removed (but notnecessarily) from the lumen 208 and a medical device 406 may beintroduced through the lumen 208 before passing through the incision 003and into the anatomical space 001, as shown in FIG. 24.

Although not shown, a medical device may be introduced into the incisionwhile bypassing the first elongated member and/or second elongatedmember (and/or third elongated member). Moreover, the first elongatedmember may remain, may be removed or partially removed.

FIG. 25 illustrates an embodiment whereby a guide wire 407 is introducedthrough the lumen 208 before passing through the incision 003 and intothe anatomical space 001. As shown in FIG. 26, once the guide wire 407is inside the anatomical space 001, the second elongated member 200 maybe rotated in the opposite direction of the initial rotation so that thehelical tine 205 is disengaged from the surface 000. The secondelongated member 200 is then withdrawn in a proximal direction.

Persons of ordinary skill in the art will understand and appreciate thata wide range of changes and modifications could be made to theembodiments described in detail above. As such, it is to be understoodthat the following claims, including all equivalents, are intended todefine the scope of this invention.

It should be appreciated that any of the first, second and/or thirdelongated members may have one or more lumens there through. Such lumensmay have a variety of cross-sections, diameter length, radius length,shape and contours. Moreover, the lumens may be multi-lumen ormulti-channel.

It should be appreciated that as discussed herein, a subject may be ahuman or any animal. It should be appreciated that an animal may be avariety of any applicable type, including, but not limited thereto,mammal, veterinarian animal, livestock animal or pet type animal, etc.As an example, the animal may be a laboratory animal specificallyselected to have certain characteristics similar to human (e.g. rat,dog, pig, monkey), etc. It should be appreciated that the subject may beany applicable human patient, for example.

It should be appreciated that various sizes, dimensions, contours,rigidity, shapes, flexibility and materials of any of the embodimentsdiscussed throughout may be varied and utilized as desired or required.

It should be appreciated that elongated members (first, second, andthird) and their related components discussed herein may can take on allshapes along the entire continual geometric spectrum of manipulation ofx, y and z planes to provide and meet the anatomical and structuraldemands and requirements. Size and shape of the elongated members(first, second, and third) during or prior to operation could also bemanipulated by varying their compliance.

The devices, systems, compositions, computer program products, andmethods of various embodiments of the invention disclosed herein mayutilize aspects disclosed in the following references, applications,publications and patents and which are hereby incorporated by referenceherein in their entirety:

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1. U.S. Pat. No. 6,423,051 B1 to Kaplan, et al., Jul. 23, 2002, “Methodsand Apparatus for Pericardial Access”.

2. U.S. Pat. No. 6,156,009 to Grabek, J., Dec. 5, 2000, “Apparatus forAccessing the Pericardial Space”.

3. U.S. Pat. No. 6,592,552 B1 to Schmidt, C., Jul. 15, 2003, “DirectPericardial Access Device and Method”.

4. U.S. Pat. No. 6,162,195 to Igo, et al., Dec. 19, 2000, “Method andApparatus for Accessing the Pericardial Space”.

5. U.S. Patent Application Publication No. US2008/0108945 A1 to Kaplan,et al., May 8, 2008, “Methods and Apparatus for Pericardial Access”.

6. U.S. Pat. No. 7,309,328 B2 to Kaplan et al., Dec. 18, 2007, “Methodsand Apparatus for Pericardial Access.”

In summary, while the present invention has been described with respectto specific embodiments, many modifications, variations, alterations,substitutions, and equivalents will be apparent to those skilled in theart. The present invention is not to be limited in scope by the specificembodiment described herein. Indeed, various modifications of thepresent invention, in addition to those described herein, will beapparent to those of skill in the art from the foregoing description andaccompanying drawings. Accordingly, the invention is to be considered aslimited only by the spirit and scope of the following claims, includingall modifications and equivalents.

Still other embodiments will become readily apparent to those skilled inthis art from reading the above-recited detailed description anddrawings of certain exemplary embodiments. It should be understood thatnumerous variations, modifications, and additional embodiments arepossible, and accordingly, all such variations, modifications, andembodiments are to be regarded as being within the spirit and scope ofthis application. For example, regardless of the content of any portion(e.g., title, field, background, summary, abstract, drawing figure,etc.) of this application, unless clearly specified to the contrary,there is no requirement for the inclusion in any claim herein or of anyapplication claiming priority hereto of any particular described orillustrated activity or element, any particular sequence of suchactivities, or any particular interrelationship of such elements.Moreover, any activity can be repeated, any activity can be performed bymultiple entities, and/or any element can be duplicated. Further, anyactivity or element can be excluded, the sequence of activities canvary, and/or the interrelationship of elements can vary. Unless clearlyspecified to the contrary, there is no requirement for any particulardescribed or illustrated activity or element, any particular sequence orsuch activities, any particular size, speed, material, dimension orfrequency, or any particularly interrelationship of such elements.Accordingly, the descriptions and drawings are to be regarded asillustrative in nature, and not as restrictive. Moreover, when anynumber or range is described herein, unless clearly stated otherwise,that number or range is approximate. When any range is described herein,unless clearly stated otherwise, that range includes all values thereinand all sub ranges therein. Any information in any material (e.g., aUnited States/foreign patent, United States/foreign patent application,book, article, etc.) that has been incorporated by reference herein, isonly incorporated by reference to the extent that no conflict existsbetween such information and the other statements and drawings set forthherein. In the event of such conflict, including a conflict that wouldrender invalid any claim herein or seeking priority hereto, then anysuch conflicting information in such incorporated by reference materialis specifically not incorporated by reference herein.

We claim:
 1. An apparatus for accessing a subject's anatomical spacehaving a surface, the apparatus comprising: a first elongated membercomprising a proximal end and a distal end, said distal end comprising asharp end; a second elongated member comprising a proximal end, a distalend, a first middle portion adjacent to said distal end, and a secondmiddle portion adjacent to said proximal end, said second middle portionof said second elongated member including a helical groove, and saiddistal end comprising a helical tine; a third elongated membercomprising a longitudinal aperture, a distal end, a middle portion, anda proximal end, wherein said third elongated member at leastsubstantially encloses said first elongated member and said secondelongated member; and a driving mechanism including: a driver tab, saiddriver tab adapted to pass through said longitudinal aperture of saidthird elongated member and engage said helical groove of said secondelongated member, wherein: if said driver tab is moved distally thensaid tab drives said second elongated member in a distal direction; ifsaid driver tab is moved proximally then said tab drives said secondelongated member in a proximal direction, wherein said helical tine isadapted to: engage and penetrate said surface, and wherein when saidsecond elongated member is turned, said helical tine lifts said surfacein a proximal direction.
 2. The apparatus of claim 1, wherein said firstelongated member comprises at least one lumen.
 3. The apparatus of claim2, wherein said second elongated member is inside said at least onelumen of said first elongated member.
 4. The apparatus of claim 3,wherein sharp end of said first elongated member is configured as asharp rim.
 5. The apparatus of claim 3, wherein said second elongatedmember comprises at least one lumen.
 6. The apparatus of claim 2,wherein said second elongated member is outside said at least one lumenof said first elongated member.
 7. The apparatus of claim 6, whereinsaid second elongated member is at least one lumen, wherein said atleast one lumen of side second elongated member is outside said lumen ofsaid lumen of said first elongated member.
 8. The apparatus of claim 6,wherein said sharp end of said first elongated member is configured as apoint.
 9. The apparatus of claim 6, wherein said end comprises at leastone of the following; beveled structure, serrated structure, taperedstructure, or cutting edge structure.
 10. The apparatus of claim 1,wherein said second elongated member is outside said first elongatedmember.
 11. The apparatus of claim 10, wherein said second elongatedmember comprises at least one lumen, wherein said at least one lumen ofsaid second elongated member is outside said first elongated member. 12.The apparatus of claim 10, wherein sharp end of said first elongatedmember is configured as a point.
 13. The apparatus of claim 10, whereinsaid end comprises at least one of the following; beveled structure,serrated structure, tapered structure, or cutting edge structure. 14.The apparatus of claim 1, wherein said second elongated member comprisesat least one lumen.
 15. The apparatus of claim 1, wherein said advancingof said surface in contact with said sharp end is caused by either: a)said lift of the surface; b) said lift of the surface and a movement ofsaid first elongated member in distal direction; c) said lift of thesurface and a movement of said second elongated member in a proximaldirection; or d) said lift of the surface, a movement of said firstelongated member in a distal direction and a movement of said secondelongated member in a proximal direction.
 16. The apparatus of claim 1,wherein said helical tine is defined by a lateral cross-section, whereinsaid lateral cross-section of said helical tine has an area that definesthe geometry of the surface being lifted to provide a surface contact.17. The apparatus of claim 1, wherein said anatomical space comprises apericardial space.
 18. The apparatus of claim 17, wherein said surfaceis the parietal pericardium.
 19. The apparatus of claim 1, wherein saidanatomical space comprises a kidney, a brain, a blood vessel, aperitoneal cavity, a spinal cord, an intra-abdominal space, anintrathoracic space or any space in the body bounded by a membrane ormembranous entity.
 20. The apparatus of claim 19, wherein said surfaceis a renal capsule, a dura mater, a blood vessel wall, a peritoneum, adural lining of the spinal cord, a pleura, a seurosa, or any othermembrane in the body.
 21. The apparatus of claim 1, further comprisingan access needle, said access needle adapted to be navigated andinserted into the anatomical space.
 22. The apparatus of claim 21,wherein said first elongated member and said second elongated member areconfigured to be used in conjunction with said access needle.
 23. Theapparatus of claim 22, wherein said conjunction is an insertion throughsaid access needle.
 24. The apparatus of claim 1, further comprising apressure sensing means configured to identify the differentpressure-frequency regimes of the tissues through which said elongatedmembers are being moved.
 25. The apparatus of claim 1, wherein saidapparatus is adapted to be visible on a medical imaging modality. 26.The apparatus of claim 25, wherein said medical imaging modalitycomprises at least one of magnetic resonance imaging, computedtomography, fluoroscopy, ultrasound, or other radiological modalities.27. The apparatus of claim 25, wherein said medical imaging modalityfurther comprises display means for displaying said sharp end's positionor communication means for communicating said sharp end's position. 28.The apparatus of claim 1, further comprising switchable means forholding said first elongated member in a fixed position with respect tosaid second elongated member.
 29. The apparatus of claim 1, wherein saidthird elongated member is further configured to retain said firstelongated member and said second elongated member to a movement that isat least substantially longitudinal as defined by the proximal anddistal directions.
 30. The apparatus of claim 1, wherein said thirdelongated member further comprises a side port.
 31. The apparatus ofclaim 30, wherein said side port is adjacent to said proximal end ofsaid third elongated member.
 32. The apparatus of claim 1, furthercomprising means for stabilizing said third elongated member on asubject's skin.
 33. The apparatus of claim 1, further comprising abumper disposed to said middle portion of said third elongated member.34. The apparatus of claim 33, wherein said bumper comprises at leastone of the following: silicone rubber, silicon, rubber, plastic,polymer, cloth, metal, foam, or any type of composite material orsubstance.
 35. The apparatus of claim 1, wherein said first middleportion further comprises an L-shaped groove.
 36. The apparatus of claim35, further comprising a restricting tab adapted to pass through saidlongitudinal aperture and engage said L-shaped groove, therebyrestricting said second elongated member regarding its distallongitudinal movement.
 37. The apparatus of claim 1, further comprisingactuator means for longitudinally driving said helical tine in aproximal and/or distal direction.